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Trial record 9 of 170 for:    gastroenterology | Recruiting Studies | United States

Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis (EoE)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by University of Wisconsin, Madison
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02775045
First received: May 13, 2016
Last updated: June 28, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to improve the overall management of patients with Eosinophil Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the endoscopy procedure. The investigators plan to identify a biomarker in the blood (a measurable substance) that tracks with disease activity and will reduce the need for follow-up endoscopies.

Condition Intervention
Eosinophilic Esophagitis Other: Observation Period

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Eosinophil Esophagitis symptom score [ Time Frame: 8 weeks ]

Biospecimen Retention:   Samples With DNA
55 mL of blood will be drawn during V1 and V2. The blood will be drawn to save serum, for flow cytometry to answer the research questions, to isolate plasma and purify eosinophils for banking of whole cell protein and RNA, and to allow for genetic analysis of DNA. DNA will be isolated for directed genetic analysis of genes related to eosinophil biology and inflammation associated with EoE. Currently, these include ORMDL3, eotaxin-3, and IL-13 and may include others upon identification in the literature. This limited analysis is not expected to be sufficient for subject identification nor is it expected that the genes will be predictive of any other disease process. The genetic portion of the blood draw will not be optional.

Estimated Enrollment: 50
Actual Study Start Date: August 30, 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Eosinophil esophagitis
Adult patients (>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 eosinophil/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy.
Other: Observation Period
8 week observational period

Detailed Description:
By definition, Eosinophil Esophagitis involves the presence of eosinophils in the esophageal mucosa. Although incompletely understood, the pathophysiology of Eosinophil Esophagitis is thought to include food allergen driven inflammation in the esophageal mucosa that triggers release of mediators for recruitment of eosinophils. The mediators, such as eotaxin, invoke eosinophil activation and trafficking into the esophageal tissue. The subsequent release of mediators from eosinophils and other cells, including mast cells and basophils, promotes inflammation and fibrosis resulting in Eosinophil Esophagitis symptoms. This protocol focuses on early eosinophil activation events in Eosinophil Esophagitis in the peripheral circulation, specifically activation of surface β1 integrin, as a biomarker for disease activity reflecting eosinophils destined for trafficking into the esophagus. Demonstrating a correlation between disease activity and a peripheral biomarker may ultimately facilitate a timelier, less invasive and less costly management strategy for Eosinophil Esophagitis.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients (>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 EOS/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy.
Criteria

Inclusion Criteria:

  • Male or female with no health concerns that might affect the outcome of the study,
  • Age 18 years of age and older
  • Esophageal dysfunction with a predominant symptom of solid food dysphagia and/or esophageal food impaction
  • Esophageal eosinophilia (>15 eosinophils/HPF) shown on biopsy
  • In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.

Exclusion Criteria:

  • Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed health problems are definitive exclusion but decisions regarding major health problems not listed will be based upon the judgment of the investigator,
  • Pregnant or lactating females or has a planned pregnancy during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02775045

Contacts
Contact: Jen Bagley, RN (608) 262-7344 jlbagley@medicine.wisc.edu
Contact: Gina Crisafi, BS 608-265-4554 gmc@medicine.wisc.edu

Locations
United States, Wisconsin
UW Madison School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53792
Contact: Sameer Mathur, MD/PhD    608-262-2804    sm4@medicine.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Sameer Mathur, MD/PhD UW Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02775045     History of Changes
Other Study ID Numbers: 2016-0508
R21AI122103-01A1 ( U.S. NIH Grant/Contract )
Study First Received: May 13, 2016
Last Updated: June 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University of Wisconsin, Madison:
EoE

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2017